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Palliative care - in the control of pain in terminal illness, these conditions
should not necessarily be a deterrent to use.
4.5 Interactions with other medicinal products and other forms of
interaction
Alcohol: enhanced sedative and hypotensive effects.
Anti-arrhythmics: There may be delayed absorption of mexiletine.
Antibacterials: The opioid analgesic papaveretum has been shown
to reduce plasma ciprofloxacin concentration. The manufacturer of
ciprofloxacin advises that premedication with opioid analgesics be
avoided.
Antidepressants, anxiolytics, hypnotics: Severe CNS excitation or
depression (hypertension or hypotension) has been reported with the
concurrent use of pethidine and monoamine oxidase inhibitors (MAOIs)
including selegiline, moclobemide and linezolid. As it is possible that
a similar interaction may occur with other opioid analgesics, morphine
should be used with caution and consideration given to a reduction in
dosage in patients receiving MAOIs.
The sedative effects of morphine (opioid analgesics) are enhanced when
used with depressants of the central nervous system such as hypnotics,
anxiolytics, tricyclic antidepressants and sedating antihistamines.
Antipsychotics: possible enhanced sedative and hypotensive effect.
Antidiarrhoeal and antiperistaltic agents (such as loperamide and
kaolin): concurrent use may increase the risk of severe constipation.
Antimuscarinics: agents such as atropine antagonise morphine-induced
respiratory depression and can partially reverse biliary spasm but are
additive to the gastrointestinal and urinary tract effects. Consequently,
severe constipation and urinary retention may occur during intensive
antimuscarinic-analgesic therapy.
Metoclopramide and domperidone: There may be antagonism of the
gastrointestinal effects of metoclopramide and domperidone.
4.6 Pregnancy and lactation
Morphine Sulfate should only be used when benefit is known to outweigh
risk. As with all drugs it is not advisable to administer morphine during
pregnancy.
Morphine crosses the placental barrier. Administration during labour may
cause respiratory depression in the new born infant and gastric stasis
during labour, increasing the risk of inhalation pneumonia. Therefore, it is
not advisable to administer morphine during labour.
Babies born to opioid-dependent mothers may suffer withdrawal
symptoms including CNS hyperirritability, gastrointestinal dysfunction,
respiratory distress and vague autonomic symptoms including yawning,
sneezing, mottling and fever.
While morphine can suppress lactation, the quantity from therapeutic
doses that may reach the neonate via breast milk is probably insufficient
to cause major problems of dependence or adverse effects.
4.7 Effects on ability to drive and use machines
Morphine causes drowsiness so patients should avoid driving or operating
machinery.
This medicine can impair cognitive function and can affect a patient’s
ability to drive safely. This class of medicine is in the list of drugs included
in regulations under 5a of the Road of Traffic Act 1988. When prescribing
this medicine, patients should be told:
• The medicine is likely to affect your ability to drive
• Do not drive until you know how the medicine affects you
• It is an offence to drive while under the influence of this medicine.
• However, you would not be committing an offence (called ‘statutory
defence’) if:
° the medicine has been prescribed to treat a medical or dental problem and
° you have taken it according to the instructions given by the prescriber
and in the information provided with the medicine and
° it was not affecting your ability to drive safely.
4.8 Undesirable effects
The most serious hazard of therapy is respiratory depression (see also 4.9
Overdose). Morphine Injection contains sodium metabisulfite, which may
rarely cause severe hypersensitivity reactions and bronchospasm.
The commonest side-effects of morphine are nausea, vomiting,
constipation, drowsiness and dizziness. Tolerance generally develops
with long term use, but not to constipation.
Other side effects include the following:
Anaphylaxis: Anaphylactic reactions following intravenous injection have
been reported rarely.
Cardiovascular: facial flushing bradycardia, palpitations, tachycardia,
orthostatic hypotension.

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INFORMATION FOR HEALTHCARE PROFESSIONALS
1 NAME OF THE MEDICINAL PRODUCT
Morphine Sulfate 10mg/ml Solution for Injection
Morphine Sulfate 15mg/ml Solution for Injection
Morphine Sulfate 30mg/ml Solution for Injection
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
The symptomatic relief of severe pain; relief of dyspnoea of left ventricular
failure and pulmonary oedema; pre-operative use.
4.2 Posology and method of administration
Morphine Sulfate may be given by the subcutaneous, intramuscular or
intravenous route. The subcutaneous route is not suitable for oedematous
patients. The dosage should be based on the severity of the pain and
the response and tolerance of the individual patient. The epidural or
intrathecal routes must not be used as the product contains a preservative.
Adults:
Subcutaneous or intramuscular injection:
10mg every four hours if necessary (the dose may vary from 5-20mg
depending on the individual patient).
Slow intravenous injection (2mg/minute):
Quarter to half of corresponding intramuscular dose not more than four
hourly.
Elderly and debilitated patients: The dose should be reduced
because of the depressant effect on respiration. Caution is required.
Children: Use in children is not recommended.
Hepatic impairment:
A reduction in dosage should be considered in hepatic impairment.
Renal impairment:
The dosage should be reduced in moderate to severe renal impairment.
For concomitant illnesses/conditions where dose reduction may be
appropriate see 4.4 Special warnings and precautions for use.
4.3 Contraindications
Acute respiratory depression, known morphine sensitivity, biliary colic
(see also biliary tract disorders 4.4 Special Warnings and Precautions),
acute alcoholism. Conditions in which intracranial pressure is raised,
comatose patients, head injuries, as there is an increased risk of
respiratory depression that may lead to elevation of CSF pressure. The
sedation and pupillary changes produced may interfere with accurate
monitoring of the patient. Morphine is also contraindicated where there is
a risk of paralytic ileus, or in acute diarrhoeal conditions associated with
antibiotic-induced pseudomembranous colitis or diarrhoea caused by
poisoning (until the toxic material has been eliminated).
Phaeochromocytoma (due to the risk of pressor response to histamine
release).
4.4 Special warnings and precautions for use
Morphine should be given in reduced doses or with caution to patients
with asthma or decreased respiratory reserve (including cor pulmonale,
kyphoscoliosis, emphysema, severe obesity). Avoid use during an
acute asthma attack (see 4.3 Contraindications). Opioid analgesics
in general should be given with caution or in reduced doses to patients
with hypothyroidism, adrenocortical insufficiency, prostatic hypertrophy,
urethral stricture, hypotension, shock, inflammatory or obstructive bowel
disorders, or convulsive disorders.
Opioids such as morphine should either be avoided in patients with biliary
disorders or they should be given with an antispasmodic.
Morphine can cause an increase in intrabiliary pressure as a result
of effects on the sphincter of Oddi. Therefore in patients with biliary
tract disorders morphine may exacerbate pain (use in biliary colic
is a contraindication, see 4.3). In patients given morphine after
cholecystectomy, biliary pain has been induced.
Caution is advised when giving morphine to patients with impaired liver
function due to its hepatic metabolism (see 4.2 Posology).
Severe and prolonged respiratory depression has occurred in patients
with renal impairment who have been given morphine (see 4.2 Posology).
Dependence can develop rapidly with regular abuse of opioids but is
less of a problem with therapeutic use. Abrupt withdrawal from persons
physically dependent on them precipitates a withdrawal syndrome, the
severity of which depends on the individual, the drug used, the size and
frequency of the dose and the duration of drug use. Great caution should
be exercised in patients with a known tendency or history of drug abuse.
Dosage should be reduced in elderly and debilitated patients (see 4.2
Posology).

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106963/2

3. HOW MORPHINE INJECTION SHOULD
BE GIVEN
The usual adult dose for relief of pain by
subcutaneous injection (an injection underneath
the skin) or intramuscular injection (an injection into
a muscle) is 10mg every four hours, if necessary.
However, this can vary between 5mg and 20mg
depending on your size and response to the drug.

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2. W
HAT YOU NEED TO KNOW BEFORE YOU
ARE GIVEN MORPHINE INJECTION
Morphine Injection should not be given if you:
• are allergic to morphine sulfate or any of the other
ingredients of this medicine (listed in section 6)
• have been told you have a tumour of the adrenal
gland near your kidney called phaeochromocytoma
• have severe problems with breathing
• have increased pressure on the brain, have just
had a head injury or if you are unconscious
• are suffering from acute alcoholism
• are at risk from a blocked intestine (paralytic ileus)
• have severe stomach cramps caused by a
condition known as biliary colic
• are suffering from severe diarrhoea
Warnings and precautions
Talk to your doctor before Morphine Injection
is given to you if you:
• are using drugs or have used drugs in the past
• suffer from asthma (your doctor may decide to
administer Morphine Injection if your asthma is
controlled. However, you should not be given this
medicine if you are having an acute asthma attack)
• suffer from bronchitis (an inflammation of the
lining of the tubes in the lungs, resulting in
coughing spells accompanied by thick phlegm
and breathlessness) or emphysema (a lung
condition which leaves you struggling for breath)
• suffer from cor-pulmonale (a type of heart failure)
• are severely obese
• have a severely deformed spine
• are suffering from mental illness brought on by an
infection
• have liver problems
• have kidney problems
• have problems with your bile duct
• suffer from an enlarged prostate gland (in men) or
have difficulty passing urine
• have an under-active thyroid or adrenal gland
• have low blood pressure
• are in a state of severe shock
• are very run down

Customer

1. W
HAT MORPHINE INJECTION IS AND
WHAT IT IS USED FOR
Morphine is one of a group of medicines called
opioid analgesics, which are used to relieve
moderate to severe pain. Morphine is used for
the relief of severe pain. It is also used to treat
breathlessness caused by fluid in the lungs and as a
pre-medication before operations.

• have bowel disease, such as Crohn’s disease or
ulcerative colitis
• suffer from blockages of the bowel
• suffer from convulsions (fits)
• are elderly
• are feeling weak and feeble
If any of the above applies to you, speak to your doctor
or nurse before Morphine Injection is given to you.
Children
This medicine is not recommended for use in children.
Other medicines and Morphine Injection
Tell your doctor if you are taking, have recently taken
or might take any other medicines. In particular, tell
your doctor if you are taking any of the following:
• monoamine oxidase inhibitors (MAOIs) such as
moclobemide or phenelzine used in the treatment
of depression.
• tricyclic antidepressants, which are used in the
treatment of depression
• tranquillising drugs or sleeping tablets such as
diazepam, nitrazepam and temazepam.
• medicines used to treat mental illnesses, including
schizophrenia (e.g. chlorpromazine, haloperidol).
• medicines used for diarrhoea (e.g. loperamide,
kaolin).
• medicines which are used as premedication before
operations and after heart attacks such as atropine.
• medicines used to treat nausea and vomiting,
such as metoclopramide or domperidone
• mexiletine, used to control heart rhythm.
• some antihistamines, used to treat allergies,
hayfever and asthma.
• certain antibiotics, used to treat infections
(e.g. ciprofloxacin and linezolid).
• selegiline, used in the treatment of Parkinson’s
disease.
• pethidine, used to treat pain.
Morphine Injection with food, drink and alcohol
You should not drink alcohol whilst being given
Morphine Injection, as it will increase its effects.
Pregnancy and breast-feeding
You should not be given morphine if you are pregnant
or think you might be pregnant unless you have
discussed this with your doctor first. If you are given
morphine during pregnancy and become dependent
on it, there is a risk that the new-born baby may also
be dependent and suffer from withdrawal symptoms
following delivery. If you are given morphine during
labour there is a risk that you could be sick and have
breathing difficulties, or the baby could have difficulty
starting breathing. If you are breast-feeding, ask your
doctor for advice before taking this medicine.
Driving and using machines
If the injection makes you feel drowsy, do not drive
or operate machinery.
This medicine can affect your ability to drive.
Do not drive whilst taking this medicine until you
know how this medicine affects you.
It may be an offence to drive if your ability to drive
safely is affected.
There is further information for patients who
are intending to drive in Great Britain - go to
http://www.gov.uk/drug-driving-law
Morphine Injection contains sodium
metabisulfite
Sodium metabisulfite may rarely cause severe
hypersensitivity reactions and wheezing.

Measure bar should be 150mm at 100% scale

PACKAGE LEAFLET: INFORMATION FOR
THE USER
Morphine Sulfate 10mg/ml, 15mg/ml and
30mg/ml Solution for Injection
Read all of this leaflet
carefully before you
start using this medicine
because it contains
important information
for you.
- K
eep this leaflet. You may
need to read it again.
- If you have further
questions, please ask your
doctor, pharmacist or nurse.
- If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Morphine Injection is and what it is used for
2. What you need to know before you are given
Morphine Injection
3. How Morphine Injection should be given
4. Possible side effects
5. How to store Morphine Injection
6. Contents of the pack and other information

Central Nervous System: myoclonus, mental clouding, confusion (with
large doses), hallucinations, headache, vertigo, mood changes including
dysphoria and euphoria.
Gastrointestinal: dry mouth, biliary spasm.
Disorders of the eye: blurred or double vision or other changes in
vision, miosis.
Sexual dysfunction: long term use may lead to a reversible decrease in
libido or potency.
Skin: pruritus, urticaria, rash, sweating. Contact dermatitis has been
reported and pain and irritation may occur on injection.
Urinary: difficulty with micturition, ureteric spasm, urinary retention,
antidiuretic effect. Tolerance develops to the effects of opioids on the
bladder.
The euphoric activity of morphine has led to its abuse and physical and
psychological dependence may occur (see also 4.4 Special warnings and
precautions for use).
4.9 Overdose
Toxic doses vary considerably with the individual, and regular users may
tolerate large doses.
The triad of respiratory depression, coma and constricted pupils is
considered indicative of opioid overdosage with dilatation of the pupils
occurring as hypoxia develops. Death may occur from respiratory failure
Other opioid overdose symptoms include hypothermia, confusion, severe
dizziness, severe drowsiness, hypotension, bradycardia, circulatory failure,
pulmonary oedema, severe nervousness or restlessness, hallucinations,
convulsions (especially in infants and children). Rhabdomyolysis,
progressing to renal failure, has been reported in overdosage.
Treatment: The medical management of overdose involves prompt
administration of the specific opioid antagonist naloxone if coma
or bradypnoea are present using one of the recommended dosage
regimens. Both respiratory and cardiovascular support should be given
where necessary.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Morphine is obtained from opium, which acts mainly on the CNS and
smooth muscle.
Morphine is a potent analgesic with competitive agonist actions at the
μ-receptor, which is thought to mediate many of its other actions of
respiratory depression, euphoria, inhibition of gut motility and physical
dependence. It is possible that analgesia, euphoria and dependence
may be due to the effects of morphine on a μ-1 receptor subtype, while
respiratory depression and inhibition of gut motility may be due to actions
on a μ-2 receptor subtype. Morphine is also a competitive agonist at the
κ-receptor that mediates spinal analgesia, miosis and sedation. Morphine
has no significant actions at the other two major opioid receptors, the
δ- and the σ-receptors.
Morphine directly suppresses cough by an effect on the cough centre in
the medulla. Morphine also produces nausea and vomiting by directly
stimulating the chemoreceptor trigger zone in the area postrema of the
medulla. Morphine provokes the release of histamine.
5.2 Pharmacokinetic particulars
Absorption: Variably absorbed after oral administration; rapidly
absorbed after subcutaneous or intramuscular
administration.
Blood concentration: After an oral dose of 10mg as the sulfate, peak
serum concentrations of free morphine of about
10ng/ml are attained in 15 to 60 minutes.
After an intramuscular dose of 10mg, peak serum
concentrations of 70 to 80ng/ml are attained in
10 to 20 minutes.
After an intravenous dose of 10mg, serum
concentrations of about 60ng/ml are obtained in
15 minutes falling to 30ng/ml after 30 minutes and
to 10ng/ml after three hours.
Subcutaneous doses give similar concentrations
to intramuscular doses at 15 minutes but remain
slightly higher during the following three hours;
serum concentrations measured soon after
administration correlate closely with the ages of the
subjects studied and are increased in the elderly.
Half-life Serum half-life in the period ten minutes to
six hours following intravenous administration-two
to three hours; serum half-life in the period six hours
onwards-10 to 44 hours.

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Distribution: Widely distributed throughout the body, mainly
in the kidneys, liver, lungs and spleen; lower
concentrations appear in the brain and muscles.
Morphine crosses the placenta and traces are
secreted in sweat and milk.
Protein binding-about 35% bound to albumin and
to immunoglobulins at concentrations within the
therapeutic range.
Metabolic reactions: Mainly glucuronic acid conjugation to form
morphine-3 and 6-glucuronides. N-demethylation,
O-methylation and N-oxide glucuronide formation
occurs in the intestinal mucosa and liver;
N-demethylation occurs to a greater extent after
oral than parental administration; the O-methylation
pathway to form codeine has been challenged and
codeine and norcodeine metabolites in urine may
be formed from codeine impurities in the morphine
sample studied.
Excretion: After an oral dose, about 60% is excreted in the
urine in 24 hours, with about 3% excreted as free
morphine in 48 hours.
After a parental dose, about 90% is excreted in
24 hours, with about 10% as free morphine,
65 to 70% as conjugated morphine, 1% as
normorphine and 3% as normorphine glucuronide.
After administration of large doses to addicts about
0.1% of a dose is excreted as norcodeine.
Urinary excretion of morphine appears to be pH
dependent to some extent; as the urine becomes
more acidic more free morphine is excreted and
as the urine becomes more alkaline more of the
glucuronide conjugate is excreted.

Up to 10% of a dose may be excreted in the bile.
5.3 Preclinical safety data
There are no pre-clinical data of relevance to the prescriber, which are
additional to those included in other sections.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Water for injections
Sodium metabisulfite (E223)
Sodium hydroxide
Hydrochloric acid
6.2 Incompatibilities
Morphine salts are sensitive to changes in pH and morphine is liable to
be precipitated out of solution in an alkaline environment. Compounds
incompatible with morphine salts include aminophylline and sodium
salts of barbiturates and phenytoin. Other incompatibilities (sometimes
attributed to particular formulations) have included aciclovir sodium,
doxorubicin, fluorouracil, furosemide, heparin sodium, pethidine
hydrochloride, promethazine hydrochloride and tetracyclines. Specialised
references should be consulted for specific compatibility information.
6.3 Shelf life
36 months
6.4 Special precautions for storage
Do not store above 25°C. Keep container in the outer carton.
6.5 Nature and contents of container
10mg
5 × 1ml Type I glass ampoules
10 × 1ml Type I glass ampoules
15mg
5 × 1ml glass ampoules
10 × 1ml glass ampoules
30mg
5 × 1ml Type I glass ampoules
10 × 1ml Type I glass ampoules
5 × 2ml Type I glass ampoules
6.6 Special precautions for disposal
None

106963/2

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Date

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Morphine sulfate injection common leaflet

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Description

6. CONTENTS OF THE PACK AND OTHER
INFORMATION
What Morphine Injection contains
The active substance is morphine sulfate. The injection
is available in three strengths, 10mg/ml (10mg of
active ingredient in 1ml of solution), 15mg/ml (15mg
of active ingredient in 1ml of solution) and 30mg/ml
(30mg of active ingredient in 1ml of solution).
Other ingredients are water for injections, sodium
metabisulfite (E223), hydrochloric acid and sodium
hydroxide.
What Morphine Injection looks like and
contents of the pack
Morphine Injection is a colourless or almost
colourless solution, practically free from particles.
Morphine Sulfate 10mg/ml Solution for Injection
is available in cartons containing 5 × 1ml glass
ampoules and 10 × 1ml glass ampoules.
Morphine Sulfate 15mg/ml Solution for Injection
is available in cartons containing 5 × 1ml glass
ampoules and 10 × 1ml glass ampoules.
Morphine Sulfate 30mg/ml Solution for Injection
is available in cartons containing 5 × 1ml glass
ampoules and 10 × 1ml glass ampoules. It is also
available in cartons containing 5 x 2ml ampoules.
Not all strengths and pack sizes may be marketed.
Marketing Authorisation Holder: Wockhardt UK
Ltd, Ash Road North, Wrexham, LL13 9UF, UK
Manufacturer: CP Pharmaceuticals Ltd, Ash Road
North, Wrexham, LL13 9UF, UK.
Other sources of information:
To listen to or request a copy of this leaflet in Braille,
large print or audio please call, free of charge:
0800 198 5000 (UK Only)
Please be ready to give the following information:

Wockhardt UK Limited

5. H
OW TO STORE
MORPHINE INJECTION
Keep out of the sight and
reach of children.
Store below 25°C. Keep the ampoule in its outer
carton, in order to protect it from light.
Do not use this medicine if you notice signs of
discolouration.
Do not use this medicine after the expiry date,
which is stated on the carton. The expiry date refers
to the last day of that month.
Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw
away medicines you no longer use. These measures
will help protect the environment.

Customer

4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side
effects, although not everybody gets them.
Tell your doctor or nurse immediately if you
experience the following serious side effect:
• A severe allergic reaction, such as breathing
difficulties, shock or low blood pressure. If you
suffer such a reaction, you should not be given
any more morphine. Your doctor will decide on
the appropriate treatment for allergic reactions.
Difficulty in breathing and physical and
psychological dependence are possible serious
side effects. It is possible that you could become
dependent on morphine.
Side effects that are common include:
• drowsiness
• feeling sick or being sick
• constipation
• dizziness.
Apart from constipation, these side effects tend to
disappear with time.
Side effects that are less common include:
• sweating
• feeling faint on standing up
• small pupils (in the eye)
• blurred vision
• double vision or other changes in vision
• mental clouding or confusion
• mood changes, feeling extremely happy for no
particular reason, or a feeling of emotional and
mental unease (dysphoria)
• imagining things (hallucinations)
• headache
• vertigo
• facial flushing
• dry mouth
• difficulty or pain in passing urine
• passing less urine than usual
• biliary spasm (causing pain in the right side of
your abdomen, particularly after eating a meal,
which may spread towards your right shoulder)
• palpitations (being aware of your heart beat)
• slower or faster pulse
• skin rash
• wheals (lumpy, red rash) or itching
• red, itchy, scaly skin at the injection site
• pain and irritation at the injection site
• reduced sexual drive or impotence after long term
use
• muscle twitching.

Reporting of side effects
If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. You can also
report side effects directly via
the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard
By reporting side effects
you can help provide more
information on the safety of
this medicine.

Measure bar should be 150mm at 100% scale

For severe pain your doctor may give you a slow
intravenous injection (an injection given slowly into
a vein). The usual dose is quarter to half of the
intramuscular dose.
• If you are elderly, severely run down including
feeling weak and feeble, or have liver and kidney
problems the dose will be lower. You may also
be given a reduced dose if you suffer from any
of the conditions listed in section 2 entitled
“Talk to your doctor before Morphine Injection is
given to you if you:”
• Your doctor will decide the dose that is best
for you. If you do not understand what you are
being given, or are in any doubt, ask your doctor
or nurse.
If you miss a dose of Morphine Injection
If you think that an injection has been missed,
speak to your doctor or nurse.
If treatment with Morphine Injection is stopped
You should always check with your doctor before the
treatment is stopped. It is possible that you could
become dependent on morphine and have withdrawal
symptoms if it is stopped suddenly. This is more
likely if you have a tendency for drug abuse or if you
become dependent on Morphine Injection.
If you have any further questions on the use of this
medicine, ask your doctor or nurse.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.